Inclusion Criteria

Inclusion criteria:

- Histologically confirmed advanced, inoperable gastric adenocarcinoma

- age ≥18 years

- WHO performance status ≤ 2

- Stage IV

- Measurable (according to RECIST criteria) or evaluable lesion

- No previous chemotherapy, except adjuvant chemotherapy ≥ 6 months ago

- Adequate hematological function (neutrophils ≥ 1.5 x 109/l and platelets ≥ 100 x
109/l, Hb ≥ 100 g/l (after transfusion when needed)

- Adequate renal function (serum creatinine ≤ 1.25 x upper normal limit)

- Adequate liver function (total serum bilirubin ≤ 1.25 x upper normal limit or ALAT ≤
3 x upper normal limit; in case of liver metastasis: total serum bilirubin ≤ 1.5 x
upper normal limit, ALAT ≤ 5 x upper normal limit)

- AFOS ≤ 2.5 x upper normal limit (unless bone metastases)

- Consent form signed and dated before inclusion

- Able to comply with the scheduled follow-up and with the management of toxicities.

Exclusion Criteria:

- Pregnant or lactating women (or potentially fertile women not using adequate
contraception)

- Presence of CNS metastases

- Unresolved bowel obstruction or subobstruction

- Chronic diarrhea

- Clinically significant malabsorption syndrome

- Inability to swallow tablets

- Known dihydropyrimidine dehydrogenase (DPD) deficiency

- Concurrent severe and/or uncontrolled co-morbid medical condition such as
uncontrolled infection, hypertension, ischemic heart disease, myocardial infarction
within previous 6 months, congestive heart failure

- History of previous or concurrent malignancy within the previous 5 years except
curatively treated carcinoma in situ of the uterine cervix or basal cell carcinoma of
the skin

- History of prior serious allergic reactions such as anaphylactic shock.

- Peripheral neuropathy ≥ grade 2, unless related to mechanical etiology

- Concurrent use of corticosteroids unless chronic treatment (i.e. initiated > 6
months prior to study entry) at low doses (≥ 20 mg methylprednisolone or equivalent)

- History of allergy to drugs containing the excipient TWEEN 80® and/ or 5-
fluorouracil.

- Lack of physical integrity of the upper gastrointestinal tract.

- Concomitant administration of any other experimental drug under investigation:
concurrent treatment with any other anti-cancer therapy.

- Major surgery within 4 weeks prior to study treatment start, or lack of complete
recovery from the effects of major surgery.

- Patients who cannot be regularly followed up for psychological, social, family or
geographic reasons.